Enrobed core medicament

Abstract

A medicine tablet is described as a new article of manufacture. The tablet is enrobed in a gelatin coating formed by application of respective layers of elastic gelatin film to opposite sides of the tablet. The applied gelatin layers conform tightly to the tablet surface, bond securely to the tablet, and are sealed together in essentially edge-to-edge manner at a seal line which extends around the tablet at a desired place on the tablet. The gelatin layers can be colored differently from the tablet and differently from each other. A range of formulations are described for film which can be peelable from a tablet or other product core, and for films which bond to the core. A presently preferred formulation for producing tablets having a bonded tamper-evident coating comprises a water-based gelatin preparation having about 45% gelatin and about 9% plasticizer (glycerin and / or sorbitol) by weight Method and apparatus for producing such new products are also described. Product cores can be dispensed on a self-timed basis into essentially simultaneous contact with two enrobing films which are supported on locally recessed coacting rotary dies. The cores contact the films adjacent a nip between the dies at places on the films which overlie die recesses which are oversize relative to the cores.. The films deform around each core and are sealed by the dies to each other before the dies coact to cut the enrobed cores from the films. A core feeding mechanism can include an alignment device which causes the cores to have a desired orientation as they are handled by the dies.

Description

[0001] This invention pertains to film-enrobed unitary-core products such as medicine tablets, to films and film compositions for making such products, and to methods and equipment for manufacturing such products. More specifically, within a presently preferred area of that field, the invention pertains to medicines and the like comprising cores of one-piece tablet nature in various geometrical forms which are enrobed in preferably digestible or erodable films applied to the cores separately from formation of the cores; the invention also pertains to gelatin-based and other films for enrobing such cores, to methods for enrobing such cores with such films, and to equipment for performing such methods to produce such products.[0002] The pharmaceutical, vitamin and related industries have long used various ways to present their products to users in swallowable oral dosage forms, other than purely as liquids, so that persons using such products can use them conveniently and comfortably....

AI Technical Summary

Benefits of technology

[0012] This invention provides an improved dosage form, among other kinds of products, in which a solid tablet preform or core is fully enrobed in soft elastic film material, such as a gelatin film, in a relatively dry state and at relatively low temperature. Formation of the tablet can occur at times and at places segregated from the time and place where the tablet is film-enrobed. The substantially dry and low temperature nature of the tablet enrobing process is important to the integrity and life of the active ingredients in the tablet. The film enrobing the tablet can tightly bond to the tablet so that, especially when the film is distinctively colored, the enrobed tablet is tamper-evident. The enrobing films can be colored to produce monocolored or bicolored enrobed tablets. The enrobed tablets can be further processed to have enteric coatings so that when swallowed, the tablets pass through the stomach and dissolve in the intestines; the film enrobing the tablet can protect the tablet from undesirable reactions with constituents of the enteric or other coatings applied over the film. The enrobed tablet can be so enrobed as to have significantly more strength and resistance to breakage when handled or subsequently processed than the unenrobed tablet.

[0014] The invention also provides improved methods and equipment which are readily adaptable to and implementable with related procedures and machinery in place in the soft elastic gelatin capsule industry to produce the improved tablets described above. Implementation and practice of these aspects of the invention does not require large scale replacement, reworking or remanufacture of existing soft elastic gelatin encapsulation machinery or procedures, and can be accomplished rapidly and with economic efficiency and without undesired disruption of established business practices and relationships.

Problems solved by technology

The text of that review notes that, because of the problem of tampering which had been experienced with hard gelatin capsule products, many manufacturers of such products withdrew them from the market in favor of other forms of active-ingredient presentment, notably caplets.

While the procedures described in U.S. Pat. No. 4,820,524 for producing at least twice-dipped, gelatin-coated caplets are relatively simple, the machinery required for high-volume implementation of those procedures is quite complex, extensive and expensive.

Also, those procedures and that machinery are not well suited for handling solid medicament preforms in shapes other than caplet shape.

So far as is known, such equipment was not successfully built and operated.

Such teaching is inconsistent with the actual development and present state of the industry which produces soft elastic gelatin capsules.

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